MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS CL IOL; INTRAOCULAR LENS

Model Number	Z9002
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or dob, weight, ethnicity: unknown, information not provided.If implanted, give date: not applicable, as lens was removed in the initial surgery.If explanted, give date: not applicable, as lens was removed in the initial surgery.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when surgeon placed a z9002 model intraocular lens(iol) in the patient's operative eye, he noticed that the iol was ripped and it was not due to the injector.The torn lens was retrieved from eye.The incision was made larger and no sutures were required.No further information available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation ¿ yes, returned to manufacturer on 12/08/2021 section h3: device evaluated by manufacturer ¿ yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and a torn optic body as well as damaged haptics were observed.The complaint issue could be confirmed; however, it may be attributed to handling during removal, and cannot be confirmed to be related to a manufacturing problem.Therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12741003
• Report Number: 2020664-2021-07954
• Device Sequence Number: 4920327
• Product Code: HQL
• UDI-Device Identifier: 05050474530751
• UDI-Public: (01)05050474530751(17)260412
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2026
• Device Model Number: Z9002
• Device Catalogue Number: Z900200230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown